Safety and Efficacy of HRS-9190 Compared to Cisatracurium for Continuous Intravenous Infusion in Adults

NCT07446309 | Recruiting Phase 2

• 1 other identifier: HRS-9190-203
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Cisatracurium. The primary objective is to measure the duration from cessation of the study drug infusion until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). Secondary objectives include onset time, duration of action, total time of adequate muscle relaxation during surgery, and neuromuscular recovery pattern.. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Time from Cessation of Infusion to Recovery of TOFr to 0.9

  The duration (in minutes) from the cessation of the continuous intravenous infusion of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater

  From the end of continuous infusion of the study drug until the time point when TOFr ≥ 90% is first achieved, assessed intraoperatively and in the immediate postoperative period, up to 2 hours

Secondary Outcomes (11)

• Time from the Cessation of Study Drug Infusion to Recovery of T1% to 10% and 25%

  From the cessation of study drug infusion until T1% recovers to 10% and 25%, respectively, assessed intraoperatively and in the recovery period, up to 2 hours

• Time from the Cessation of Study Drug Infusion to Recovery of TOFr to 0.4 and 0.7

  From the cessation of study drug infusion until TOFr ≥ 0.4 and TOFr ≥ 0.7 are achieved, assessed intraoperatively and in the recovery period, up to 2 hours.

• Percentage of Time that Target Neuromuscular Block Level (T1% 1% to 10%) is Maintained During Study Drug Administration

  From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.

• Mean Infusion Rate of Study Drug and Mean T1%

  From the initiation of study drug infusion until its cessation, assessed intraoperatively, up to 6 hours.

• Time to Successful Airway Device Placement

  From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 3-5 minutes.

Study Arms (4)

Treatment group A: HRS-9190 under Inhalational Anesthesia

EXPERIMENTAL

Drug: HRS-9190; under Inhalational Anesthesia

Treatment group B: HRS-9190 under Intravenous Anesthesia

EXPERIMENTAL

Drug: HRS-9190; under Intravenous Anesthesia

Treatment group C: Cisatracurium under Inhalational Anesthesia

ACTIVE COMPARATOR

Drug: Cisatracurium (under Inhalational Anesthesia).

Treatment group D: Cisatracurium under Intravenous Anesthesia.

ACTIVE COMPARATOR

Drug: Cisatracurium (under Intravenous Anesthesia)

Interventions

HRS-9190; under Inhalational Anesthesia DRUG

HRS-9190; under Inhalational Anesthesia

Treatment group A: HRS-9190 under Inhalational Anesthesia

HRS-9190; under Intravenous Anesthesia DRUG

HRS-9190; under Intravenous Anesthesia

Treatment group B: HRS-9190 under Intravenous Anesthesia

Cisatracurium (under Inhalational Anesthesia). DRUG

Cisatracurium (under Inhalational Anesthesia).

Treatment group C: Cisatracurium under Inhalational Anesthesia

Cisatracurium (under Intravenous Anesthesia) DRUG

Cisatracurium (under Intravenous Anesthesia)

Treatment group D: Cisatracurium under Intravenous Anesthesia.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring elective general anesthesia surgery
• Meet specified age and body mass index (BMI) criteria
• Conform to the ASA Physical Status Classification
• Use of highly effective contraception for a specified period if applicable

You may not qualify if:

• Scheduled for specific high-risk surgical procedures
• History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders
• History of conditions affecting drug metabolism or anesthesia risk
• Abnormal laboratory values indicating significant clinical abnormalities
• Positive serology for specified infectious diseases
• Known hypersensitivity to related medications
• Recent use of medications interfering with neuromuscular function
• History of mental illness, cognitive impairment, or epilepsy
• Participation in another clinical trial within a specified period
• Any other condition deemed unsuitable by the investigator
• Pregnant or nursing women
• Unwilling to use birth control during the specified period

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanxi Provincial People'S Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

MeSH Terms

Interventions

cisatracurium

Central Study Contacts

Lei Tang

CONTACT

+0518-81220121; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-02

Locations

CN (2)